A Chemoprevention Trial to Study the Effects of High Tea Consumption on Smoking-Related Oxidative Stress
Abstract
Our overall goal is to develop a safe and feasible model for the chemoprevention of a wide range of tobacco-related - diseases. Our immediate goal, that is addressed over a 4-year study period, is to determine the effects of high tea - consumption on biological markers of oxidative stress that mediate lung cancer risk. We are conducting a 6-month randomized, controlled, double-blinded chemopreventive trial in a group of COPD subjects who are being randomized to green or black tea preparations or a control intervention (matching placebo). Levels of 8-hydroxydeoxyguanosine and 8- F2-isoprostanes will be used to measure DNA and lipid damage respectively. Changes in biomarkers of oxidative damage will be measured in urine, blood and exhaled breath condensate. The study protocol was approved by all parties in September 2003. Recruitment and screening of participants for eligibility criteria started in October 2003. By the end of December, 110 participants signed the consent form and were screened for eligibility criteria (spirometry for lung function). Eight subjects with FEVI > 85% of the standard were excluded from the study and 20 subjects dropped out during run-in and before randomization. Currently 37 eligible subjects were enrolled in the study and 32 subjects have already completed the 6-month intervention. We expect that adherence to a regular pattern of tea is feasible and quantifiable among this high risk population.
Document Details
- Document Type
- Technical Report
- Publication Date
- Feb 01, 2005
- Accession Number
- ADA441266
Entities
People
- Iman A. Hakim
Organizations
- University of Arizona